K911367 is an FDA 510(k) clearance for the BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 10, 1991, 74 days after receiving the submission on March 28, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K911367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1991 |
| Decision Date | June 10, 1991 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |